Macular Pigment Measurement Device with Data Quality Indexing Feature

ABSTRACT

A system measures macular pigment of a macula of a human eye of a subject. The system comprises a light source having a first light and a second light that modulate at variable frequencies, an input device for receiving an input indicating the frequency at which the user perceives the modulation of the first light and a second light, a display device, at least one processor, and one or more memory devices. The one or more memory devices storing instructions that, when executed by at least one processor, cause the system to (i) display, on the display device, test data corresponding to the user&#39;s inputs from the input device, (ii) determine whether the test data are valid or invalid through a curve-fitting algorithm, (iii) automatically indicate that the test data are valid or invalid.

CROSS-REFERENCE AND CLAIM OF PRIORITY TO RELATED APPLICATION

This application claims the benefit of and priority to U.S. ProvisionalPatent Application No. 61/720,737, which was filed on Oct. 31, 2012,which is incorporated herein by reference in its entirety.

FIELD OF THE INVENTION

The present invention relates to a macular pigment optical densitymeasurement instrument that measures characteristics of the patient'seye, such as macular pigment.

BACKGROUND OF THE INVENTION

The retina is the layer of nerve cells at the back of the eye, whichconvert light into nerve signals that are sent to the brain. In humans,and in other primates (but not in most other mammals, or other types ofanimals), the retina has a small yellowish area in the center of thefield of vision. That yellowish area is called the “macula.” It providesfine-resolution vision in the center of the visual field and isessential to good vision. People who suffer from macular degenerationoften lose the ability to read, recognize faces, drive, or walk safelyon unfamiliar routes.

The surrounding portions of the macula can only provide coarseresolution. This physiological feature limits and controls the number ofnerve signals that the brain must rapidly process, to form coherentrapid-response vision, and it also helps limit and control the hugenumber of rod and cone receptors that the eye must continuallyregenerate and recycle, every day. Many people do not realize the retinacan provide only coarse resolution, outside of a limited central area,because the eyes and the brain have developed an extraordinary abilityto synthesize coherent vision from a combination of fine and coarseresolution. During that type of vision synthesis, the eye muscles causethe eyes to flit back and forth over a larger field of vision, pausingat each location for just an instant while the eye quickly “grabs” afine-resolution image of a limited area. This process occurs so rapidlythat a person does not notice it happening, and does not pay attentionto how a complete visual image and impression is being assembled andupdated from combinations of fine and coarse resolution images.

There is also a peculiar anatomic structure in the retinas of humans,which points out the difference between fine resolution (provided by themacula) and coarse resolution (provided by the remainder of the retina).In humans, the blood vessels that serve the retina actually sit in frontof the retina, where they can block and interfere with incoming light,before the light reaches the retina. This is counter-intuitive, and oneshould wonder why the retina evolved with a physical handicap thatliterally gets in the way of good, clear vision. The answer is, in thoseparts of the retina, only coarse vision is being created, and bloodvessels positioned in front of the retina do not interfere with thattype of coarse vision. By contrast, in the macular region in the centerof the retina, the blood vessels in front of the retina are lacking andsupply is only from blood vessels present anywhere behind the layer ofneurons with rod and cone receptors. This is consistent with the maculaproviding fine resolution vision, which would be blocked and hindered ifthe blood vessels were located in front of the neurons, in ways thatwould intercept and blocking portions of the incoming light.

“Retinal degeneration” is a descriptive term, which refers to andincludes an entire class of eye diseases and disorders. It includes anyprogressive disorder or disease that causes the macula to graduallydegenerate, to a point that substantially impairs or damages eyesightand vision. Several major categories of retinal degeneration are known.These include: (i) age-related macular degeneration, which graduallyappears among some people over the age of about 65; (ii) diabeticretinopathy, in which problems with sugar and energy metabolism damagethe entire retina, including the macula; (iii) eye diseases that affectthe macula due to gene and/or enzyme defects, such as Stargardt'sdisease, Best's disease, Batten's disease, Sjogren-Larsson syndrome, andvarious other eye disorders that lead to gradual degeneration of themacula (and possibly other parts of the retina) over a span of time.This is not an exclusive list, and other subclasses and categories alsoare known. For example, age-related macular degeneration is subdividedinto wet and dry forms, depending on whether abnormal and disruptiveblood vessel growth is occurring in the structural layers behind theretina.

The causes and effects of macular degeneration, and efforts to preventor treat it, are described in numerous books (e.g., “MacularDegeneration,” by Robert D'Amato et al (2000) and “Age-Related MacularDegeneration,” by Jennifer Lim (2002)), articles (“Age-Related MacularDegeneration” by Berger et al (1999)) and patents, such as U.S. Pat. No.Re. 38,009, which is assigned to ZeaVision LLC, and is incorporated byreference in its entirety.

In recent years, awareness has grown, among some researchers but notamong the general public, of the roles that macular pigment plays, inthe health and longevity of the macula. Therefore, the two carotenoidpigments that create and provide the macular pigment are discussedbelow.

The Macular Pigments: Zeaxanthin and Lutein:

The macula has a yellowish color because it contains unusually highconcentrations of two specific pigments, called zeaxanthin and lutein.Both are carotenoids, similar to beta-carotene but with hydroxy groupscoupled to their end rings (the presence of one or more oxygen atomscauses a carotenoid to be categorized as a “xanthophyll”, so zeaxanthinand lutein are sometimes referred to as xanthophylls). Both of those twocarotenoids are known to be protective and beneficial, in human retinas,by mechanisms that include: (1) absorption of destructive ultravioletphotons; and (2) quenching of destructive radicals. Both of thosemechanisms, and other potential protective mechanisms, are discussedbelow.

In addition to their involvement in the macula and macular degeneration,zeaxanthin and lutein also are present in other eye structures(including the eye lens), and undesirably low levels of those twocarotenoids appear to be correlated with higher risks of disorders suchas cataracts. Accordingly, although the discussion herein focuses onmacular degeneration, it should be recognized that any comments hereinabout macular pigment levels also have varying degrees of relevance tosome other eye disorders as well. Similarly, any comments herein aboutmacular degeneration should be recognized as including disorders thatare referred to by other names (such as diabetic retinopathy,Stargardt's disease, etc.), but that involve or lead to gradualdeterioration of the macula.

The structures of zeaxanthin and lutein are very similar because theyare isomers of each other, differing only in the placement of a doublebond in one end ring. In lutein, the ring with a “misplaced” double bondis called an “epsilon” ring. All of the other end rings have “beta” ringstructures, which refer to the sequence of double bonds found inbeta-carotene's two end rings.

However, that single minor structural difference, between zeaxanthinversus lutein, has profound effects on the traits, performance, andtissue concentrations of those two different molecules, in both plantsand animals. Briefly, the lutein molecule has a bend where the epsilonring joins the “straight chain” segment between the two end rings. Thatbend, near one end, allows lutein to fit properly into ring-shaped“light-harvesting” structures, in the chloroplasts of plant cells. Sincelight-harvesting (which is part of photosynthesis) is crucial in plants,lutein evolved as a major and dominant carotenoid, in essentially allplants.

By contrast, zeaxanthin does not have a bend at either end. Since it isrelatively straight, it cannot fit properly into the circularlight-harvesting structures that help carry out photosynthesis, inplants. Therefore, it evolved in plants in ways that led to a verydifferent role in a day-night cycle, in which zeaxanthin and a similarcarotenoid called violaxanthin are converted back and forth into eachother. As a result, zeaxanthin does not accumulate in substantialquantities in most types of plants (although a few exceptions are known,such as corn and red peppers). Even in dark green plants, such asspinach or kale, lutein content is dozens or even hundreds of timesgreater than zeaxanthin content. On an aggregate basis, the total amountof zeaxanthin in typical diets in industrial nations is believed to beabout 1% (or possibly even less) of the total lutein supply.

Another important difference between zeaxanthin and lutein is thatzeaxanthin has a longer and more protective “conjugated cloud” ofelectrons surrounding it, compared to lutein. When a series of carbonatoms are bonded to each other by alternating double and single bonds,the electrons become mobile, and are no longer affixed to specific bondlocations. Those electrons form a flexible and movable electron “cloud”.This same type of cloud also appears in benzene rings and other“aromatic” organic compounds, and it is well-known to chemists.

That type of flexible and movable electron cloud is ideally suited forabsorbing high-energy radiation (in the ultraviolet, near-ultraviolet,and deep blue part of the spectrum), without suffering damage orbreakage of the molecule. In addition, a flexible and movable electroncloud is ideally suited for neutralizing and “quenching” oxygenradicals, which are aggressively unstable and destructive molecules,containing oxygen atoms having unpaired electrons. Oxidative radicalsare important damaging agents in any cells and tissues that are beingbombarded by high levels of UV radiation, since UV radiation oftenbreaks bonds that involve oxygen atoms, in ways that create unpairedelectrons where the broken bonds previously existed.

All carotenoids are assembled, in plants, from a 5-carbon precursorcalled isoprene, which has two double bonds separated by a single bond.As a result, all carotenoids have at least some sequence of alternatingdouble and single bonds, leading to a conjugated electron cloud coveringat least part of the carotenoid molecule. This is a basic and sharedtrait of all carotenoids, and it explains how carotenoids provide twocrucial benefits (i.e., absorption of UV radiation, and quenching ofdestructive radicals) that are vital to plants, which must often sit indirect sunlight for hours each day.

However, different carotenoids have conjugated electron clouds thatdifferent lengths, and different potencies and protective traits. Inparticular, there is a crucial difference between the conjugatedelectron clouds of zeaxanthin and lutein. The placement of the doublebonds in both of zeaxanthin's two end rings continues and extends thepattern of alternating double and single bonds, from the straight chain.This extends zeaxanthin's conjugated and protective electron cloud, outover a part of both of zeaxanthin's two end rings.

By contrast, the position of the double bond in lutein's “epsilon” ringdisrupts the alternating double/single bond sequence, established by thestraight-chain portion of the molecule. This disrupts and terminates theconjugated electron cloud, and it prevents the protective, UV-absorbing,radical-quenching electron cloud from covering any part of lutein'sepsilon end ring. That structural difference in their end rings becomeshighly important, because zeaxanthin and lutein are deposited intoanimal cells in ways that cause them to “span” or “straddle” the outermembranes of the cells. It causes zeaxanthin and lutein to be depositedinto animal cell membranes in a way that places them perpendicular tothe surfaces of the membrane that surrounds and encloses a cell.

It is not fully known, at a molecular level, how lutein's lack ofsymmetry, and lack of a protective conjugated electron cloud over oneend ring, affect its deposition in cells in the human macula. Forexample, it is not known whether the protective beta rings at one end oflutein are consistently or predominantly placed on either the externalor internal surfaces of cell membranes. In addition, it is not knownwhether lutein is consistently deposited, into human cell membranes, ina membrane-spanning orientation.

However, other aspects of zeaxanthin and lutein content and depositionin blood, and in the macular regions of human retinas, are well-known.Despite the rarity of zeaxanthin in food sources (as mentioned above,zeaxanthin content in typical diets is believed to be less than about 1%of the lutein supply), zeaxanthin concentrations in human blood averageabout 20% of lutein levels. This clearly indicates that the human bodydoes something that indicates a selective preference for zeaxanthin,over lutein.

Even more revealingly, zeaxanthin is even more concentrated in thecrucially important center of the human macula, which providesfine-resolution vision in humans. In the crucially important center of ahealthy human macula, zeaxanthin is present at levels that average morethan twice the concentrations of lutein. By contrast, lutein is presentin higher levels around the less-important periphery of the macula.While the mechanisms which create that pattern of deposition are notfully understood, it recently has been reported that certain enzymesthat appear to be involved will clearly bind to zeaxanthin withrelatively high affinity under in vitro conditions; however, those sameenzymes will not bind to lutein with any substantial affinity (Bhosaleet al 2004).

Accordingly, these differences in how zeaxanthin and lutein aredeposited in the macula provide strong evidence that the macula wantsand needs zeaxanthin, more than lutein. The patterns of deposition, andthe known structural and electron cloud differences, suggest andindicate that the macula wants and needs zeaxanthin, and it uses luteinonly if and when it cannot get enough zeaxanthin.

This belief is also supported by another important finding. The maculamay attempt to convert lutein into zeaxanthin. However, the conversionprocess cannot convert lutein into the normal stereoisomer of zeaxanthinfound in plants and in the diet (the 3R,3′R stereoisomer). Instead, itconverts lutein into a different stereoisomer that has never been foundin any food sources or mammalian blood. That non-dietary isomer has oneend ring with the conventional “R” configuration; however, the secondend ring has an unnatural “S” configuration that is never found in thenormal diet. That S-R isomer (and R-S isomer) is called meso-zeaxanthin.

Consequently, while lutein may have benefits, a growing body ofknowledge and evidence indicates that zeaxanthin is the ideal carotenoidfor helping prevent and treat the class of eye diseases that fall intothe category of retinal degeneration.

To address problems associated with retinal degeneration in a patient,instruments are needed to help measure the macular pigment within thepatient's eye. While various instruments exist that can perform thisfunction, improvements are needed to provide instruments that are moreaccurate, easier to use, and less time consuming. For example, manyinstruments require the taking of multiple measurements from a patientand some or all of the data may not be accurate such that a re-test isneeded.

The present invention is directed to an improved instrument that canhelp to automatically determine whether the data captured by theinstrument is acceptable for providing proper results. If it is, theinstrument instructs the operator that the data is acceptable. If thedata is not acceptable, the instrument instructs the operator to takenew data from the patient.

SUMMARY OF THE INVENTION

According to one aspect of the present invention, a system measuresmacular pigment of a macula of a human eye of a user. The systemcomprises a light source having a first light and a second light thatmodulate at variable frequencies, an input device for receiving an inputindicating the frequency at which the user perceives the modulation ofthe first light and a second light, a display device, at least oneprocessor, and one or more memory devices. The one or more memorydevices storing instructions that, when executed by at least oneprocessor, cause the system to (i) display, on the display device, testdata corresponding to the user's inputs from the input device, (ii)determine whether the test data are valid or invalid through acurve-fitting algorithm, (iii) automatically indicate that the test dataare valid or invalid.

According to another aspect of the present invention, a method of usinga measurement system for measuring a macular pigment of an eye of asubject, comprising: (i) receiving input data from a subjectcorresponding to when the subject perceives a flicker in two lights; and(ii) displaying the input data in a manner that automatically indicateswhether the input data is valid or invalid.

Additional aspects of the invention will be apparent to those ofordinary skill in the art in view of the detailed description of variousembodiments, which is made with reference to the drawings, a briefdescription of which is provided below.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a system for measuring macular pigment including a measurementdevice and a computer with a display.

FIG. 2 is a graph of the user inputs from the system of FIG. 1.

FIG. 3 illustrates the display of the data inputs from the system ofFIG. 1 when the data are acceptable.

FIG. 4 illustrates the display of a second set of data inputs from thesystem of FIG. 1 when the data are acceptable.

FIG. 5 illustrates the display of a third set of data inputs from thesystem of FIG. 1 when the data are unacceptable.

DETAILED DESCRIPTION

FIG. 1 illustrates a MPOD detection system 10 that includes aheterochromatic flicker photometry (HFP) instrument 12 and a computer 14for providing inputs and viewing outputs on its display. The HFPinstrument 12 is typically electronically coupled to the computer 14 viaa wire connection 16, although a wireless connection is possible aswell. As shown, the HFP instrument 12 is a commercially available fromZeaVision LLC, Chesterfield, Mo., and is sold under the trademarkQuantifEYE®.

The HFP instrument 12 includes an input device 18 allowing a testsubject to provide an input when he or she perceives a flicker duringthe test. Generally, the HFP instrument 12 has a target arranged to beviewed by the test subject with one eye (left or right) through theviewing window 20. The target includes a blue light and a green lightarranged to undergo a modulation in opposing phases. The modulationdecreases from an initial modulation frequency at which an initialflicker of the first light and second light is not perceivable by thetest subject (e.g., decreased at a rate of between 3 Hz per second and 7Hz per second). The test subject inputs a response from the input device18 to indicate when he or she perceives the flicker. The modulationfrequency at which the test subject can perceive the flicker provides afirst data point that is later used to provide a correlation to an MPODvalue for that patient.

The ratio of the blue light and the green light for the target is thenchanged (e.g., increased blue light and decreased green light) for thenext data point. The frequency modulation decreases from an initialmodulation frequency at which an initial flicker of the first light andsecond light is not perceivable by the test subject, to a point at whichthe test subject perceives the flicker. The test subject againindicates, via the input device 18, the frequency at which he or she canperceive the flicker. This is a second data point. The process continuesat different relative values (ratios) of blue light and green light tocreate multiple data points.

FIG. 2 illustrates a graph of the data derived from the test for atypical test subject. Each of the ten data points on FIG. 2 representsthe test subject's input on the input device 18 for ten different testconditions having different ratios of green light to blue light(measured in decibels “dB” along the x-axis). The modulation frequencyon the y-axis is the flicker rate for the target, and each data pointrepresents a corresponding flicker rate at which the test subject beganto perceive a flicker. The HFP instrument 12 and its procedures aredescribed in U.S. Pat. No. 7,390,090, which is hereby incorporated byreference in its entirety. Additionally, alternative procedures forusing the HFP instrument 12 are described in an article entitled “A NewDesktop Instrument for Measuring Macular Pigment Optical Density Basedon a Novel Technique For Setting Flicker Thresholds.” Ophthalmic &Physiological Optics. 29(2):127-137, March 2009, by van der Veen, Rob L.P.; Berendschot, Tos T. J. M.; Hendrikse, Fred; Carden, David;Makridaki, Maria; Murray, Ian J, which is also hereby incorporated byreference in its entirety.

Because the HFP instrument 12 relies on the test subject inputs via theinput device 18, there can be a tendency for errors when macular pigmentdensity is being measured. The test subject must fixate on a target orstimulus that will change (i.e., the target will begin to flicker atdifferent rates). While some test subjects readily understand theoperating instructions and take the test appropriately, others testsubjects have difficulty understanding and following instructions and,therefore, their macular pigment measurement is inaccurate. A testsubject may anticipate the change in frequency and respond via the inputdevice too early when they perceive no flicker. The test subject mayblink multiple times for eye comfort and/or clarity at a critical pointin the test at which the frequency is being decreased and becomesperceptible to the test subject, but he or she misses it due to blinkingThe patient may simply have problems hitting the input device properly,or be distracted during a few data pints in the test. When these testsubject errors are introduced into the system, the smooth curve in FIG.2 (which is good for ultimately measuring the MPOD value) can bereplaced by scattered data that is not as useful for measuring data, oris entirely inaccurate at providing the test subject's MPOD value.

Further, when the test subject begins providing bad data, the operator(e.g., an assistant in an eye care practice) may not catch the errorswhen looking at a graph like FIG. 2 on the display of the computer 14.Operator interpretation/assessment of each test subject's graph must betaught to instrument operators. The teachings would include graph trendline shape, alignment of responses as “points on the graph” to the trendline, and reaching predefined minimum or macular pigment saturation.While well trained instrument operators can interpret the results of theHFP instrument 12 on the computer 14 accurately, employee turnover ineye care practices is common and utilization of the instrument may notbe so intuitive to new test subjects.

The present invention seeks to overcome the aforementioned problems ofthe MPOD detection system 10 by providing an automatic data qualityindex. The data quality index (DQI) may utilize one or morecurve-fitting algorithms to ensure the data from the test subject isaccurate. Based on the results of the curve-fitting algorithm, thedisplay of the computer 14 can provide the operators and the testsubject with an indication of whether the data was accurate (i.e.,acceptable) or, if a retest is needed. These types of outputs on thedisplay of the computer 14 are shown in with respect to FIGS. 3-5.

In FIG. 3, the curve-fitting algorithm has been used to develop a curve30 that best matches the test subject's data. The curve-fittingalgorithm may be a polynomial-curve fitting algorithm, such as the leastsquares methodology, which is known in the art. Based on how well thecurve fits the data, the DQI is established to provide the test subjectand operator with an indication of whether the test data is accurateenough to determine the patient's MP (Macular Pigment) value. In FIG. 3,the MP display field 32 is shown above the graph and its MP value forthe test subject is 0.38. Additionally, a MP bar-graph 36 is scaled from0.0 to 1.0 on the right side of the graph and provides a visualindicator 38. Here, the visual indicator 38 is also indicating a MPvalue of 0.38, just as show in the MP display field 32. Because the MPvalue of 0.38 is above a predetermined threshold value for the MP (e.g.,0.2), the operator and test subject understand the patient's MP value isacceptable. More importantly, the curve-fitting process for the curve 30automatically determines the accuracy and acceptability of the data, asindicated by the “Accept” in the message field 34 appearing below thegraph. Thus, the test for the right eye is complete. The left eye maynow be tested in a similar manner.

The message field 34 is preferably color-coded to indicate the data'sacceptability. A green, yellow or red region on the DQI message 34indicates to accept data, to accept data with caution and retesting mayyield better results, or to reject the score because it is inaccurate.Alternatively, instead of the 3-color-code scheme in the DQI messagefield 34, (e.g., Red, Yellow and Green), a 2-color-code scheme may existto make it clear when to re-test.

In FIG. 4, the curve-fitting algorithm has been used to develop anothercurve 40 that best matches another test subject's data. The MP valuefield 42 is shown above the graph and its value for the test subject isagain 0.38 (coincidentally the same as in FIG. 3, although it surelycould be different). The message field 44 includes an “Accept” messageto indicate the curve 40 fit the data well enough and, thus, the datawas accurate.

In FIG. 5, the curve-fitting algorithm has been used to develop anothercurve 50 that best matches yet another test subject's data. In FIG. 5,the MP display field 52 has a value of 0.14, which is relatively lowsuggesting the patient has a lower amount of macular pigment. The MPbar-graph 56, which is scaled from 0.0 to 1.0 on the right side of thegraph, also provides a visual indicator 58 of the MP value at 0.14.However, this test subject's data is unacceptable, as indicated by the“Inaccurate, Retest Patient” message in the DQI message field 54appearing below the graph. Thus, the low MP value may have something todo with the testing itself, and not the patient's macula. This subjectshould be re-tested.

The test can include both central macula data and peripheral maculardata, as disclosed in the aforementioned article and U.S. Pat. No.7,390,090, which have been incorporated by reference. Curves for bothtypes of data can be displayed at the same time (i.e., two curves in thedisplay screen). And, data problems can be assumed (and a retest isneeded) when the two curves have certain overlapping characteristics.

When the test data is accurate, the test data is used to correlate tothe patient's MPOD through logarithmic functions, which are taught bythe aforementioned article and/or U.S. Pat. No. 7,390,090. This MP valueis a dimensionless value (e.g., 0.0 to 1.0 as shown in the MP bar graphs36, 46, and 56 in FIGS. 3-5) indicative of the amount of pigment locatedat the macula. It should be noted that the MPOD as measured by one formof instrument, such as the system 10, may be different from the MPODmeasured by another form of MPOD-measuring instrument (e.g.reflectometer). Nevertheless, the skilled artisan will recognize thatcorrelations can be developed between the MPOD values of a first type ofinstrument and the MPOD values of a second type of instrument.

If a patient's MPOD value is determined to be low, zeaxanthin and/orlutein supplementation may be recommended to increase the patient'smacular pigment. By conducting follow-up periodic testing of thepatient, the effects of supplementation should become noticeable.Zeaxanthin supplementation can be in the form of daily tablets orcapsules, such as those supplements sold by ZeaVision LLC ofChesterfield, Mo.

Each of these embodiments and obvious variations thereof is contemplatedas falling within the spirit and scope of the claimed invention, whichis set forth in the following claims.

1-18. (canceled)
 19. A method of using a measurement system formeasuring macular pigment from an eye of a subject, comprising:receiving, from an input device associated with the measurement system,input data from the subject corresponding to when the subject perceivesa flicker in two lights; and displaying, on a display device associatedwith the measurement system, the input data in a manner thatautomatically indicates whether the input data is valid or invalid. 20.A method of using a measurement system for measuring macular pigmentfrom an eye of a subject, comprising: receiving, from an input deviceassociated with the measurement system, input data from a subjectcorresponding to when the subject perceives a flicker in two lights; andautomatically displaying, on a display device associated with themeasurement system, whether the input data is acceptable for measuringthe macular pigment of the subject.
 21. The method of claim 19, furthercomprising: arranging the two lights at an initial modulation frequency;decreasing modulation frequency of the two lights; and wherein thereceiving input data occurs when a modulation frequency is reached atwhich the subject indicates that the flicker in the two lights isperceived.
 22. The method of claim 21, wherein the modulation frequencyat which the subject perceives a flicker is between about 15 Hz andabout 35 Hz.
 23. The method of claim 21, wherein the modulationfrequency is decreased at a rate of between 3 Hz per second and 7 Hz persecond.
 24. The method of claim 19, wherein the two lights include ablue light and a green light.
 25. The method of claim 19, furthercomprising: determining whether the test data is valid or invalidthrough a curve-fitting algorithm; and displaying the curve that isfitted to the test data on the display device.
 26. The method of claim19, further comprising displaying on the display device, amacular-pigment value indicative of the amount of the subject's macularpigment.
 27. The method of claim 26, wherein the macular-pigment valueis displayed on a scaled bar graph.
 28. The method of claim 19, whereinthe manner of automatic indication includes a message field providing amessage on the display device.
 29. The method of claim 19, wherein themanner of automatic indication includes the use of at least two colors,a first color indicating the test data is valid, and a second colorindicating the test data is invalid.
 30. The method of claim 20, furthercomprising: arranging the two lights at an initial modulation frequency;decreasing modulation frequency of the two lights; and wherein thereceiving input data occurs when a modulation frequency is reached atwhich the subject indicates that the flicker in the two lights isperceived.
 31. The method of claim 30, wherein the modulation frequencyat which the subject perceives a flicker is between about 15 Hz andabout 35 Hz.
 32. The method of claim 30, wherein the modulationfrequency is decreased at a rate of between 3 Hz per second and 7 Hz persecond.
 33. The method of claim 20, wherein the two lights include ablue light and a green light.
 34. The method of claim 20, furthercomprising: determining whether the test data is acceptable through acurve-fitting algorithm; and displaying the curve that is fitted to thetest data on the display device.
 35. The method of claim 20, furthercomprising displaying on the display device, a macular-pigment valueindicative of the amount of the subject's macular pigment.
 36. Themethod of claim 35, wherein the macular-pigment value is displayed on ascaled bar graph.
 37. The method of claim 20, wherein the manner ofautomatic display includes a message field providing a message.
 38. Themethod of claim 20, wherein the manner of automatic display includes theuse of at least two colors, a first color indicating the test data isacceptable, and a second color indicating the test data is unacceptable.